Spyre reports Phase 2 IBD data for SPY001, SPY002, sets Q4 rheumatic readouts
Spyre says both antibodies hit primary and secondary endpoints in ulcerative colitis, while three SKYWAY sub-studies finished enrollment ahead of schedule.
Spyre Therapeutics announced second quarter 2026 results on August 4, 2026, alongside updates on its two ongoing Phase 2 programs. Part A enrollment of the SKYLINE platform trial in ulcerative colitis is complete, with topline induction data for SPY001 announced in April 2026 and for SPY002 in June 2026, and SPY003 data expected in September 2026.1
On efficacy and safety, the company said both SPY001 and SPY002 were tolerated with a safety profile in line with comparators already in the treatment class, and each met its primary endpoint, with statistically significant reductions in the Robart's Histopathology Index of 9.2 points for SPY001 and 10.7 points for SPY002.1 On secondary measures, clinical remission and endoscopic improvement rates were 40% and 51% for SPY001, and 33% and 42% for SPY0021, and the modified Mayo Score fell by 3.7 points from baseline at Week 12 for both compounds.1 Part B of SKYLINE, a randomized placebo-controlled stage testing monotherapies and combinations, is currently enrolling, with induction data expected in 2027.1
In rheumatic disease, all three sub-studies of the SKYWAY basket trial testing SPY072 in RA, PsA and axSpA have completed enrollment ahead of schedule.1 The company said RA data are expected in September 20261, while PsA and axSpA data are expected in the fourth quarter of 2026.1
On finances, Spyre said cash, cash equivalents and marketable securities totaled $1,145.3 million as of June 30, 20261, following a stock offering in April 2026 that generated $435.2 million in net proceeds.1 The company stated its cash runway is expected to extend into the second half of 2029.1
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